MAUDE Adverse Event Report: VISTAKON ACUVUE 2 BRAND CONTACT LENSES; SOFT CONTACT LENS, DISPOSABLE

Lot Number B00GRQV

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Corneal Edema (1791); Corneal Clouding/Hazing (1878); Pain (1994); Red Eye(s) (2038); Uveitis (2122)

Event Date 01/14/2014

Event Type  Injury  

Event Description

Our office was contacted by an optometrist who reported a patient complaining of "intense burning" on insertion on her right lens on the previous night.The patient wears a lens od only.Exam revealed a loss of epithelium over the entire cornea, with edema and corneal haze.The patient's lid was red and swollen.The provider reported a mild uveitis with 1+ cells in the anterior chamber.The patient was referred to a corneal specialist.One sealed blister was returned.The parameters were measured and a visual inspection was performed.The lens met company standards for base curve, center thickness, and diameter.No visual attributes were observed.Not enough solution was available to test ph and conductivity.

Manufacturer Narrative

A device history review was performed: the batch record did not show any abnormalities in monomer and solution testings.All parameters tested were within specification.All sterilization requirements were successfully completed.No quality events associated with the lot.The lot history review indicated lot b00gqv was manufactured under normal conditions.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: ACUVUE 2 BRAND CONTACT LENSES
• Type of Device: SOFT CONTACT LENS, DISPOSABLE
• Manufacturer (Section D): VISTAKON; jacksonville FL
• Manufacturer Contact: rose harrell ; p.o. box 10157; jacksonville, FL 32247 ; 9044433647
• MDR Report Key: 3667232
• MDR Text Key: 4319799
• Report Number: 1033553-2014-00017
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Lot Number: B00GRQV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/11/2014
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR